AQURE System…

Date

Feb. 10, 2016

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Terminated

Filed by

Radiometer America Inc

Product

AQURE System; Model Number: 933-599. The AQURE System manages blood gas and immunoassay analyzers.

Reason

The AQURE System has a design error regarding sample type in which sample type may be specified for some results and left blank for other results. The fact that the sample type field is left blank in some cases could lead to misinterpretation of results.

Distribution pattern

Worldwide Distribution-US (nationwide) including the states of PA, GA, MI, OH, VA, FL, AL, TX, OR, OK, TN, NY, and MA, and the countries of Austria, Czech Republic, Denmark, Estonia, United Emirates, Kuwait, Qatar, Saudi Arabia, Oman, Jordan, Finland, France, Germany, Hungry, Ireland, United Kingdom, Italy, Netherlands, Norway, Poland, Spain, Sweden, Switzerland, Australia, New Zealand, China, Hong Kong, Taiwan, Japan, Russia, Singapore, South Africa, Republic of Korea, and Malaysia.

Quantity

375

Codes and lots

Model Number: 933-599 Version 1.8.3

Recall started

Dec. 29, 2015

Device type

Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph

Root cause (FDA)

Device Design

What the company told customers

Customers were sent a notification letter on 12/29/15. The notification states that the AQURE System can be used, but to eliminate the potential confusion, blank fields for sample type are to be interpreted as not specified. Customers are told that a Radiometer representative will be in contact to schedule a visit or a remote session. During the visit or remote session the representative will run a database script on the AQURE system which will serve for two purposes: 1. Update existing patient results where the sample type field is blank to include Not specified. 2. Install a so-called database-trigger, which will include the text Not specified in a blank sample type field for future patient results. An upgraded version of the AQURE software will include modified device drivers to ensure that Not specified is inserted if the device transmits an empty field for sample type. The new software version will be installed by local engineer when available.

Recall number

Z-0748-2016

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-0748-2016. The agency record governs; check it and the company before acting.